Minimally Invasive Surfactant Therapy Followed by CPAP (MISTCPAP) in Preterm Infants With RDS

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

There is a reducing incidence of pneumothorax, PIE and the combined outcome of death or BPD since the development of Surfactant therapy. A policy of intubation with surfactant administration and mechanical ventilation has become a standard therapy of infants at high risk of RDS. However, initial stabilization with CPAP and, if necessary, given rescue surfactant therapy has remained the standard therapy for preterm infants. Evidence reveals similar results with regard to mortality and neonatal morbidity between the above two strategies. The investigators intend to develop a method of minimally invasive surfactant therapy followed by early CPAP (MISTCPAP) in preterm Infants with high risk of RDS for improving the outcomes and reducing the incidence of BPD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital
• Treatments: Pulmonary Surfactants

Criteria

Inclusion Criteria:

1. Very preterm infants (GA < 32 wks) admitted to NICU at CMUH from 1 February 2012 to 31 January 2013 are enrolled for the study

2. Less than 36 hours of age

3. Clinical signs of RDS with requirement of FiO2 ≥ 0.35

Exclusion Criteria:

1. Previous Intubation or in imminent need of IMV because of e.g. apnea, severe bradycardia or other deterioration not attributed to RDS, e.g. shock

2. Major congenital malformations

3. No parental consent